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Betaseron Pregnancy Registry
This study is currently recruiting participants.
Verified by Kendle International, May 2008
Sponsors and Collaborators: Kendle International
Bayer
Information provided by: Kendle International
ClinicalTrials.gov Identifier: NCT00317564
  Purpose

This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to Betaseron® at conception and during pregnancy compared to rates from women in the general US population. Secondarily, the Registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. This study will be conducted in the United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare Pharmaceuticals and will be managed by Kendle International, Inc. Late Phase Registries & Epidemiology (Kendle). The scientific conduct and analysis of the Registry will be overseen by an Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).


Condition Phase
Birth Defects
Pregnancy Complications
Multiple Sclerosis
Phase IV

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Interferon beta-1b
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Betaseron Pregnancy Registry

Further study details as provided by Kendle International:

Estimated Enrollment: 375
Study Start Date: April 2006
Estimated Study Completion Date: December 2010
Detailed Description:

Because informed consent is required, the Registration process must be initiated by the patient. An HCP who contacts the Registry may request an authorization for release of medical information packet or have the eligible patient contact the Registry directly. Once an eligible subject provides consent and permission to obtain information from her HCP, the Registry will contact the obstetric HCP and obtain information on demographics, history of previous pregnancies, maternal risk factors, pregnancy outcome, and neonatal health. Data will be collected from the maternal HCP at enrollment, during the second trimester (around week 20), and at outcome. Data on live born infants will be collected from the pediatrician at 3 months of age. If a birth defect is reported, targeted follow-up will be conducted.

NOTE: This study has previously been posted by Berlex, Inc. which has since been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of this pregnancy registry.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Study Population

US only

Criteria

Inclusion Criteria:

The subjects must meet the following criteria for registration:

  • Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
  • Diagnosed with MS prior to or during the current pregnancy
  • Exposed to Betaseron® on or after the first day of the patient's last menstrual period
  • Provide verbal consent to participate in the Registry
  • Verbally provide contact information for herself, her HCP, and the infant's HCP (as applicable)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317564

Contacts
Contact: Angie Graves, MBA 800-478-7049 registries@kendle.com
Contact: Jennifer Pocoski, PharmD 973-487-2827 jennifer.pocoski@bayer.com

Locations
United States, North Carolina
Kendle International Inc. Recruiting
Wilmington, North Carolina, United States, 28405
Principal Investigator: Deborah L Covington, DrPH            
Sub-Investigator: Angie Graves, MBA            
Sponsors and Collaborators
Kendle International
Bayer
Investigators
Study Chair: Deborah L Covington, DrPH Kendle International Inc.
Study Director: Mark Rametta, DO Bayer
  More Information

Official website for the Betaseron Pregnancy Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Kendle International Inc. ( Deborah Covington, DrPH )
Study ID Numbers: 308740
Study First Received: April 21, 2006
Last Updated: May 9, 2008
ClinicalTrials.gov Identifier: NCT00317564  
Health Authority: United States: Institutional Review Board

Keywords provided by Kendle International:
Birth Defects
High Risk Pregnancy
Multiple Sclerosis

Study placed in the following topic categories:
Autoimmune Diseases
Pregnancy Complications
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon-beta
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Congenital Abnormalities
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009